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510(k) Data Aggregation

    K Number
    K112880
    Device Name
    CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
    Manufacturer
    FREEDOM MEDITECH, INC.
    Date Cleared
    2013-01-31

    (489 days)

    Product Code
    MYC
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    FREEDOM MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearPath DS-120® Lens Fluorescence Biomicroscope is indicated for use to detect autofluorescence of the crystalline lens.
    Device Description
    The major functional components of the ClearPath DS-120® Lens Fluorescence Biomicroscope are an optics unit and a laptop personal computer. The only components that contact the patient are a manually adjustable headrest (in/out) and a motorized adjustable chin rest (up/down). The adjustable optics window does not contact the patient.
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